System and method to analyze waveforms for electromyography testing

ABSTRACT

A device includes an EMG processing application operable with a processing module to receive an output signal from EMG testing, wherein the output signal represents electrical activity of at least one muscle. The EMG processing application is operable to process the output signal to detect at least one type of waveform of a plurality of types of waveforms from the output signal and display the detected at least one type of waveform.

CROSS-REFERENCE TO RELATED PATENTS

The present U.S. Utility Patent Application claims priority pursuant to35 U.S.C. § 120 as a continuation in part application to U.S. patentapplication Ser. No. 14/604,715, entitled, “SYSTEM AND METHOD TO ANALYZEWAVEFORMS FOR ELECTROMYOGRAPHY TESTING,” filed Jan. 24, 2015, which isincorporated by reference herein and made part of the present U.S.Utility Patent Application for all purposes. The prior U.S. Utilitypatent application Ser. No. 14/604,715 claims priority pursuant to 35U.S.C. § 119(e) to U.S. Provisional Application Ser. No. 61/931,591,entitled, “SYSTEM AND METHOD TO ANALYZE WAVEFORMS FOR ELECTROMYOGRAPHYTESTING,” filed Jan. 25, 2014, which is incorporated by reference hereinand made part of the present U.S. Utility Patent Application for allpurposes.

BACKGROUND Technical Field

This disclosure relates generally to medical devices and moreparticularly, but not exclusively, to systems and methods forelectromyography testing.

Description of Related Art

The statements in this section provide a description of related art andare not admissions of prior art. An examiner, such as a physician,neurologist, or physiatrist, performs nerve conduction studies onpatients. A complementary part of nerve conduction studies iselectromyography (EMG). EMG results can reveal nerve dysfunction, muscledysfunction or problems with nerve-to-muscle signal transmission. EMGtesting includes a technique for detecting electrical activity producedby skeletal muscles. Motor neurons transmit electrical signals thatcause muscles to contract. In one type of EMG testing, a needleelectrode is inserted directly into a muscle and detects the electricalactivity in that muscle. Electrical activity of the muscle is sensed bythe electrode. An EMG translates these signals into graphs of waveformsdisplayed on a monitor. In addition, an audio-amplifier is used so theactivity can be heard. The examiner may listen to the audiorepresentation and/or view the waveforms on the monitor to evaluate theelectrical activity of the muscle as normal or abnormal. Theinterpretation of an EMG test is thus very subjective due to theevaluation of the waveforms by the examiner.

As such, a need exists to improve EMG testing and in particular toprovide a more objective analysis of the waveforms produced by the EMGtesting. The potential for computers to analyze the signal/waveforms iswithin the scope of the present application.

SUMMARY

In an embodiment, a device includes a display; a memory; and aninterface configured to receive an output signal of a needleelectromyography (EMG) device, wherein a needle electrode is insertedinto at least one muscle and records electrical activity of at least onemuscle fiber in the at least one muscle and wherein the output signalrepresents one or more waveforms of the electrical activity of the atleast one muscle fiber in the at least one muscle. The device furtherincludes at least one processing device and an EMG processingapplication stored in the memory and operable with the processing deviceto: process the output signal; compare the processed output signal to aplurality of output patterns; detect at least one pattern of theplurality of output patterns using the processed output signal; access awaveform database that includes the plurality of output patterns andassociated waveform types of electrical activity of muscle fibers,wherein the associated waveform types of the electrical activity of themuscle fibers include one or more of: insertional activity waveform,spontaneous activity waveform, volitional activity waveform orrecruitment waveform; identify at least one type of waveform of theplurality of types of waveforms associated with the detected at leastone pattern; and display the identified at least one type of waveform onthe display.

In an embodiment, the at least one processing device is further operableto diagnose at least one condition based on the identified at least onetype of waveform.

In an embodiment, the memory includes a waveform database that includesthe plurality of output patterns and the associated waveform types ofelectrical activity of muscle fibers, wherein the associated waveformtypes of electrical activity of muscle fibers include one or more of:Normal insertion, Increased insertion, Fasciculations, Fibrillations, orPositive waves.

In an embodiment, the processing device is further operable to: quantifya number of motor units generating the output signal; and determine acount of repetitions for one or more of the motor units during a portionof the output signal.

In an embodiment, the memory includes a patient database for storing theoutput signal and the identified at least one type of waveform.

In an embodiment, a method includes receiving an output signal of aneedle EMG device, wherein the output signal represents electricalactivity of at least one muscle fiber; processing the output signal;identifying a first waveform type in the output signal of the electricalactivity of the at least one muscle fiber; identifying a second waveformtype in the output signal of the electrical activity of the at least onemuscle fiber; and displaying a first name of the first waveform type anda second name of the second waveform type and a number of each of thefirst waveform types and the second waveform types on a display, whereinthe first waveform type and the second waveform type of the electricalactivity of the at least one muscle fiber includes two or more of:insertional waveform, spontaneous activity waveform, volitional activitywaveform or recruitment waveform.

In an embodiment, the method further includes diagnosing at least onecondition based on at least one of the first waveform type or the secondwaveform type. In an embodiment, the method further includes storing aplurality of reference output patterns and associated waveform types ina waveform database.

In an embodiment, the method further includes detecting an outputpattern in the output signal of the needle EMG device; accessing thewaveform database; correlating the detected output pattern in the outputsignal with one of the plurality of reference output patterns stored inthe waveform database; and identifying the associated waveform type inthe waveform database with the correlated reference output pattern.

In an embodiment, the method further includes quantifying a number ofmotor units generating the output signal and determining a count ofrepetitions for one or more of the motor units during a portion of theneedle EMG output.

In an embodiment, the method further includes storing a patientdatabase, wherein the patient database includes the output signal of theneedle EMG and a name of the first waveform type and a name of thesecond waveform type and a number of each of the first waveform type andthe second waveform type.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of apparatus and/or methods in accordance withembodiments of the disclosure are now described, by way of example only,and with reference to the accompanying drawings, in which:

FIG. 1 illustrates a schematic block diagram of an embodiment of asystem for performing EMG testing;

FIG. 2 illustrates a schematic block diagram of an embodiment of adevice for analyzing EMG testing results;

FIG. 3 illustrates a logic flow diagram of an embodiment of a method foranalyzing EMG testing results;

FIG. 4 illustrates a schematic block diagram of another embodiment of asystem for performing EMG testing;

FIG. 5 illustrates a schematic block diagram of an embodiment of agraphical user interface displayed on a device for analyzing EMG testingresults;

FIG. 6A illustrates a logical flow diagram of an embodiment of a methodfor analyzing EMG testing results from audio;

FIG. 6B illustrates a logical flow diagram of an embodiment of a methodfor analyzing EMG testing results from an input signal;

FIG. 7A illustrates a logical flow diagram of an embodiment of anothermethod for analyzing EMG testing results from audio;

FIG. 7B illustrates a logical flow diagram of an embodiment of anothermethod for analyzing EMG testing results from an input signal;

FIG. 8 illustrates a schematic block diagram of an embodiment of awaveform database; and

FIG. 9 illustrates a schematic block diagram of an embodiment of apatient database.

DETAILED DESCRIPTION

The description and drawings merely illustrate the principles of variousembodiments. It will thus be appreciated that those skilled in the artwill be able to devise various arrangements that, although notexplicitly described or shown herein, embody the principles herein andin the claims and fall within the spirit and scope of the disclosure.Furthermore, all examples recited herein are principally intendedexpressly to be only for pedagogical purposes to aid the reader inunderstanding the principles of the embodiments and the conceptscontributed by the inventor to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and embodiments, as well as specific examplesthereof, are intended to encompass equivalents thereof.

An embodiment may include a data acquisition system including an analogto digital converter, a computer processor and a waveform memory inwhich is stored digital data from an analog to digital (A/D) convertercorresponding to an input signal. A processor provides a triggerresponsive to a characteristic of a frequency component or anycomponents of the input signal to cause a memory to save waveform datain a memory. A frequency characteristic may be determined, for example,by carrying out a synchronized recursive discrete Fourier transformwhich is updated for the selected frequency component or components witheach new sample from the A/D converter.

As explained in U.S. Pat. No. 4,816,813A, a waveform segmentconstituting several points of digitized waveform data from a digitizeris stored in a pixel memory which has a number of memory locationscorresponding to the number of pixels in the horizontal screen width ofa raster scan video screen. As each new data point is written into asequentially higher location in the memory, the data at the memorylocation that is a selected number of memory locations lower,constituting the desired number of pixels in the waveform segment, iserased. When a full new segment of data is in the waveform memory, thecontents of the memory is provided to a raster scan graphics controlunit which causes a new raster scan frame to be written on the videomonitor screen. Only the portion of the waveform corresponding to thesegment of waveform data in the waveform memory is illuminated on thescreen. New data continues to be written into the waveform memory untilanother full segment of waveform data is in the memory and all previouswaveform data points have been erased. The content of the waveformmemory then is again provided to the raster scan graphics control whichcauses another raster scanned frame to appear on the video monitorscreen, with the new segment of waveform illuminated on the video screendisplaced sequentially from the previously displayed waveform segment.

In an embodiment described herein, once any audio is generated duringthe needle EMG exam, the EMG Processing Application 154 should startproducing output in a form of written types of waveforms which may bedisplayed on the display and/or may be recorded in the memory 12 and/ormemory 60 of the device 150. Alternatively, the input could be recordedand processed remotely, as describe in U.S. Pat. No. 8,972,263, which ishereby incorporated by reference herein.

An input signal represents an electrical signal (activity) generated bya muscle and detected, e.g., by a needle electrode inserted into themuscle. An event represents a type of a waveform (EMG activity) to berecognized by a device as described herein.

FIG. 1 illustrates a system 10 for stimulating and recording responsesfrom a muscle 36 which may be a human muscle or other living organism.The system 10 includes a stimulating device 42 which may be anelectrode/needle. The stimulating device 42 may be used to stimulate anerve 34 that then may activate the muscle 36. A measuring device 40includes another electrode/needle to record response signals from themuscle 36 during the stimulation of the nerve 34. In another embodiment,the nerve 34 may not be stimulated. The measuring device 40 may beconnected to an amplifier 28 which may amplify the signals from themuscle 36 during normal activity without stimulation.

The amplifier 28 may be connected to an A/D converter 24 to convert theanalog signal from the amplifier 28 to a digital signal and may beconnected to an audio amplifier 26 to amplify the signal from theamplifier 28 to a sufficient level in order to be heard by an evaluatingindividual. The audio amplifier 26 may be connected to a speaker 30and/or an earphone 32. The control unit 16 may be connected to the audioamplifier 26 to control the operation (such as volume and on/off) of theaudio amplifier 26, and the control unit 16 may be connected to otheruser interface devices such as a keyboard, mouse, etc.

The output of the amplifier 28 may be connected to a display device 22which may display the signal obtained from the muscle 36, and the outputof the amplifier 28 may be connected to an A/D converter 24 to convertthe analog signal from the muscle 36 to a digital signal. The digitalsignal is transmitted to a switch 14 which may be controlled andconnected to the processor 18 which may be connected and controlled bythe control unit 16. The processor 18 may open the switch 14 to allowthe digital signal to be stored in the pixel/waveform memory 12, oralternatively, the processor 18 may close the switch 14 to prevent thestorage of the digital signal in the memory 12. The processor 18 maycontrol the memory 12 to activate the transmission of the stored digitalsignals from the memory 12 to the display 22 and/or to the audioamplifier 26.

In operation, the pulse generator 20 activates the stimulating device 42to transmit one or more stimulating pulses from the pulse generator 20to the nerve 34 which activates the muscle 36. The response signal fromthe muscle 36 is transmitted to the device 150 and the amplifier 28.

During the needle EMG exam, the electrical signal from the muscle 36 istransmitted to the device 150 and the amplifier 28. The analog signal istransmitted to the audio amplifier 26 and transmitted to the speaker 30and the earphone 32 so that the user can listen to the signal generatedby the muscle 36. In addition the analog signal may be converted to adigital signal and may be selectively stored in the memory 12 under thecontrol of the control unit 16 through the processor 18. A device 150may be positioned sufficiently close to the speaker 30 in order todetect the audio from the audio amplifier 26.

FIG. 2 illustrates a schematic block diagram of an embodiment of device150. The device 150 may be wirelessly or wired connected to theprocessor 18. The device 150 may include an antenna 52 to communicatewith the processor 18, a display 52 to display information for the userof the device 150, a microphone 54 in order to receive the audio signalsfrom the speaker 30 and buttons 56 a-d in order to control the device150. The device 150 may determine the type of waveform for example bythe type of muscle being examined and from the audio emitted from thespeaker 30. The screen may be pressure/touch sensitive in order torespond to pressure such as tapping in order to select and control thedevice 150 instead or in addition to using buttons 56 aa-d.

The device 150 is operable to not only recognize the type of waveform asa predetermined sound pattern from the muscle 36, but also couldquantify it for the given muscle 36, and if needed, populate appropriatetables for example as the table shown below and store the table withinthe memory 60 of the device 150 or the memory 12.

TABLE 1 Insertional Volitional Activity Recruitment Activity SpontaneousActivity MUP MUP MUP MUP Max Max Insertional Fibs +Wave Fasics Poly AmpDur Config Pattern Amp Pattern MaxEffort Gastrocnemius R Normal NoneNone Few None Decr Decr Poly Norm SI Decr Reduced Max Medial HeadTibialis Anterior R Increased None 1+ None None Norm Norm Poly Norm SIDecr Reduced Max Vastus Lateralis R Normal None None None None Norm NormPoly Norm Norm Reduced Max Vastus Medialis R Normal None None None NoneNorm Norm Norm Norm SI Decr Reduced Max

As seen in Table 1, the associated waveform types of the electricalactivity of the muscle fibers include one or more of: insertionalactivity waveform, spontaneous activity waveform, volitional activitywaveform or recruitment waveform.

The device 150 may include an EMG processing application 154. The EMGprocessing application 154 recognizes sound patterns in the audio inputsignal and is operable to recognize one or more types of waveform as apredetermined sound pattern in the audio input signal. In an embodiment,the EMG processing application 154 may include similar processingtechniques as in speech recognition software, wherein the spoken word isthe audio input and the written word is the output (what is on thedisplay 50).

In the EMG processing application 154 of the device 150, the audiogenerated in response to the muscle 36 activity is input to themicrophone 54 of the device 150. The EMG processing application 154 willrecognize a sound pattern in the audio that is associated with aparticular waveform, and the written type (name) of the waveform will bethe output and displayed on the display 50 and may be transmitted to theprocessor 18 and stored within the memory 12.

During use, the user places the device 150 next to the audio source(speaker) 30 of the EMG equipment, tap or select the start tab orbutton, choose the muscle group, the specific muscle from a menu 58 fromthe display 135, and thus start the recording of the audio signal fromthe muscle 36 (waveform recognition). Alternatively, tapping orselecting the “Default Settings” of the device 150 would do the same.Once any audio is generated during the needle EMG exam, the EMGprocessing application 154 should start producing output in a form ofwritten types of waveforms which may be displayed on the display 50and/or may be recorded in the memory 12 and/or memory 60 of the device150. Alternatively, the input could be recorded locally and thenprocessed remotely. See, for example, U.S. Pat. No. 8,972,263, which isincorporated by reference herein, that describes a system operable toperform local voice recognition and remote voice recognition.

The input data (the output signal/electrical activity/sound) of afibrillation potential produces a name (event) “fibrillation potential”on the screen 50 of the device 150. The input data (the outputsignal/electrical activity/sound) of positive sharp wave will producethe event “positive sharp wave” or abbreviation “PSW” on the screen. Alist of waveform types may include one or more of: Polyphasic units,Normal insertion, Increased insertion, End-plate noise, End-plate spike,Fasciculation, Fibrillations, Positive waves, Complex repetitivedischarges (CRD), Myotonic discharges, Myokymic discharges,Neuromyotonic charges, and their subsets, but not limited thereto.Waveforms from the muscle 129 may be a short waveform with a maximum fora longer duration of up to 20 ms. (Although a few types of waveforms canrun in trains).

Embodiments herein provides for quantifying the events and populatingtables with waveform data such as Table 1. Furthermore, embodimentsherein may export the waveform data to an appropriate report generatorprogram. Embodiments provide for the ability of when examining aparticular muscle, having choice of selecting the desired muscle fromthe menu, and may not allow the operator to move on to a second muscleunless adequate motor unit sampling has been completed for the firstmuscle and the number of needle passes is considered satisfactory.Embodiments may be adapted to distinguish non-speech audio input events(the desired EMG sound pattern events) from speech or other audio input(non-desired events).

The EMG Processing Application 154 may be adapted to synthesizereference pattern data from stored audio reference pattern data in amemory 60 of the device or memory 12 and patterns similar to storedreference pattern data. For example, correlations or other calculationsmay be performed to determine the differences between data representingthe reference pattern and data representing the input. The referencepattern data with the correlations having the least differences may thenbe determined. For the review process, the EMG Processing Application154 may be adapted to allow: recorded input/sound review or time basedevents (recognized EMG sounds) or both. For example, the input/sound offibrillation potential will produce a name of an event, such as“fibrillation potential” on the display 50. The input/sound of apositive sharp wave will produce the name positive sharp wave orabbreviation PSW (event) on the display 50. In addition, recordedinput/sound may be synchronized with time based events (i+ii) where i isrecorded input/sound review only, and ii is time based events review,only (recognized EMG inputs/sounds).

FIG. 3 illustrates a logic flow diagram of an embodiment of a method 70for performing waveform recognition by the device 150. In step 72,device 50 displays a welcome screen with tabs or buttons for selecting,“START RIGHT” “START LEFT” “REVIEW AUDIO” “REVIEW EVENTS” “REVIEW ALL”.In step 74, device 50 receives a selection of “START RIGHT” or “STARTLEFT”. In step 76, the device 50 displays a disclaimer with an option“Do not show it again”. In step 78, the device 50 displays a list of themuscles. The list of the muscles can be scrolled down starting with“default settings”. Alternatively muscles may be grouped. In that casethe second (next screen) would have the tabs of the groups of themuscles, again starting with “Default settings”. Tapping on the tab of agroup of muscles would open the next screen—list (tabs) of individualmuscles within the given group. Once a muscle to be examined is selectedby tapping the appropriate tab in step 80, the device displays a newscreen and recording and waveform recognition is initiated in step 84.Events can be recognized and listed with the time of occurrence and thenumber of occurrences can be added up and displayed as a sum.

Insertional activity (initial needle passes) in step 86 can be added upas well, and the sampling can be labeled as satisfactory if sufficientnumber of needle passes has been detected. Then, once the screen isclosed (by tapping on the screen) it reverses back to the priorscreen—the list (tabs) of individual muscles within the given group—thebackground of the tab with the name of the examined muscle will turngreen. Red background shows inadequate sampling. For example, once thetesting is finished the screen with the list of all muscles shows theexamined muscle tabs as either green, indicating adequate sampling or asred, indicating inadequate sampling. Adequate sampling may also besignaled to a specific signal (sound). A recording of an alreadycompleted muscle may also be selected from a menu on the display forreview. Recording can be displayed continuously with recognized timebased events synchronized with the sound recording in step 88.

Alternatively, a list of time based events or only the input/soundrecording can be reviewed separately. In another embodiment therecording can be continuous (in default settings without the need toselect individual muscles) again. A recording can be displayedcontinuously with recognized events synchronized with the soundrecording. Alternatively, a list of time based events or only theinput/sound recording can be reviewed separately.

In an embodiment at least twelve (12) events of IA (insertionalactivity, both normal and/or increased) are needed per muscle examinedfor an adequate muscle sampling. Between each muscle examined there is apause (when needle is removed from one muscle and inserted into anothermuscle during the EMG procedure). The pause (certain length of time)will trigger the summation process of IAs as well as other events. Ineither case, the entire recording can be scrolled back and forth. At theend of the exam, the entire file can be saved within the memory 60 ofthe device 150 or memory 12 of device 150. The data is saved andexported to the appropriate report generator program in step 88.

FIG. 4 illustrates a schematic block diagram of another embodiment of anEMG system 110 for performing EMG testing. In an embodiment, the EMGsystem 110 is operable to activate a muscle 112 and record electricalactivity responses from the muscle 112. The EMG system 110 detects theelectrical potential generated by muscle cells when these cells areelectrically or neurologically activated. In an embodiment, the muscle112 is a human muscle but may also be a non-human muscle such as from ananimal. The EMG system 110 includes a stimulating device 114, such as anelectrode or needle, for stimulating nerves 34 that activate the muscle112. The EMG system 100 also includes a sensing device 116, such asanother electrode or needle, for recording the electrical activity fromthe muscle 112 in response to the stimulation of the nerve. Generally,the sensing device 116 includes EMG electrodes placed on the surface ofthe skin overlying the muscles being evaluated, or needle electrodeswhich penetrate the tissue being studied. In addition to these activeelectrodes, a ground reference electrode is generally also applied tothe patient.

An electrode interface 118 is operably coupled to the stimulating device114 and sensing device 116 and to pulse generator module 120. The pulsegenerator module 120 includes a pulse control module 122 thatcommunicates with the stimulating device 114, sensing device 116 andcontrol module 124. The pulse generator module 120 receives commandsfrom the control module 124, such as registration information,transmission frequency commands, amplifier gain commands, transmittercontrol commands, power saving mode, etc. The pulse generator module 120processes these commands and responsively configures the stimulatingdevices 114 and sensing devices 116 accordingly.

In another embodiment, during EMG testing, the muscle 12 may not bestimulated by stimulating device 114. Instead, the sensing device 116senses electrical activity during normal motion of the muscle 112 orvolitional activation.

The detected signal 130 from the sensing devices 116 is generally weakand typically measured in microvolts. As such, the electrical interface118 amplifies the detected signal 130 sensed from the muscle 112.Alternatively, the electrical interface 118 transmits the detectedsignal 130 to the control module 114 that amplifies and processes thedetected signal 130. For example, control module 114 includes a digitalsignal processing (DSP) module 134 and analog processing module 134 thatprocess the detected signal 130. For example, the analog processingmodule 134 may include a preamplifier followed by one or more additionalstages of amplification that boost the detected signal to a usable levelas well as filters that minimize the effects of interference arisingfrom sources other than the muscles being studied.

In an embodiment, the DSP module 132 includes an A/D converter thatconverts the amplified detected signal to a digital signal for furtherprocessing. For example, the DSP module 132 may perform rectification ofthe amplified signal to a single polarity frequency (usually positive).The purpose of rectifying a signal is to ensure the raw signal does notaverage zero, due to the signal having positive and negative components.The DSP module 132 may analyze the signal and calculate a mean,integration and fast Fourier transform (FFT) of the signal. The DSPmodule 132 and analog processing module 134 may be one module or splitinto multiple modules with different inputs and outputs.

In an embodiment, the control module 124 further includes a memory 136to store the received detected signal 130 and processed signals, such asthe video signal 142 and audio signal 146. The audio signal 146 istransmitted to an audio output device 128, such as a speaker orearphones. The audio output device 128 generates audio 140 that may beheard by the operator. The video signal 142 is transmitted to an EMGdisplay 126, such as a computer monitor, TV screen or other type ofdisplay. The control module 124 may also generate a signal input 144that includes the audio signal 146 and/or video signal 142 or otherrepresentation of the detected signal 130. The signal input 144 may betransmitted to the user device 150 wirelessly using a wirelesstransceiver. For example, the wireless transceiver 110 may operate in aBluetooth protocol (such as a Bluetooth Low Energy Transmitter (BLE4.2)), wireless local area network protocol such as IEEE 802.11a, g, n,ac, etc. or may utilize a standard protocol in the 900 MHz range, suchas IEEE 802.11ah, Zigbee, etc., or through a short range radio frequency(RFID) protocol, cellular protocol, or other short range or long rangewireless communication protocol. In addition or alternatively, thesignal input 144 may be transmitted to the user device 150 via a wiredconnection, e.g. using a LAN or WAN protocol.

In operation, the sensing device 116 detects the electrical activityfrom the muscle 36 and generates the detected signal 130. The detectedsignal 130 is transmitted to the analog processing module 134 and/or DSPmodule 132 to generate the video signal 142 and the audio signal 146.The audio signal 146 is transmitted to the audio output device 128, suchas a speaker or earphone, so that the examiner can listen to the audio140. In addition the detected output signal 130, the output audio signal146 and/or the output video signal 142 are selectively stored in memory136 by the control module 124.

A motor unit is defined as one motor neuron and the muscle fibers thatit innervates. When a motor unit fires, the impulse (called an actionpotential) is carried down the motor neuron to the muscle. The areawhere the nerve contacts the muscle is called the neuromuscularjunction, or the motor end plate. After the action potential istransmitted across the neuromuscular junction, an action potential iselicited in all of the innervated muscle fibers of that particular motorunit. The sum of all this electrical activity is known as a motor unitaction potential (MUP). This electrophysiologic activity from multiplemotor units is the detected signal 130 typically evaluated during EMGtesting. The composition of the motor unit, the number of muscle fibersper motor unit, the metabolic type of muscle fibers and many otherfactors affect the shape of the motor unit potentials (MUPs). EMGsignals are essentially made up of superimposed motor unit actionpotentials (MUPs) from several motor units.

For a thorough analysis, the measured EMG signals can be decomposed intotheir constituent MUPs. MUPs from different motor units tend to havedifferent characteristic shapes, while MUPs recorded by the sameelectrode from the same motor unit are typically similar. Notably MUPsize and shape depend on where the electrode is located with respect tothe fibers and so can appear to be different if the electrode movesposition. The electrical source is the muscle membrane potential ofabout −90 mV. Measured EMG potentials range between less than 50 μV andup to 20 to 30 mV, depending on the muscle under observation.

Typical repetition rate of muscle motor unit firing is about 7-20 Hz,depending on the size of the muscle (eye muscles versus seat (gluteal)muscles), previous axonal damage and other factors. Damage to motorunits can be expected at ranges between 450 and 780 mV. A variety ofdifferent MUP waveforms are generated in normal and diseased muscles.

Currently, an automated machine cannot recognize the various types ofMUP waveforms or distinguish a number of MUP waveforms. Clinical EMGtesting therefore relies not only on an electromyographer's ability torecognize individual MUP waveforms occurring alone, but also occurringin combination with other MUP waveforms. Currently, an electromyographermust learn to recognize these MUP waveforms empirically by visuallyrecognizing the MUP waveforms on the EMG display 126 or by hearing theaudio 140 representing the waveforms from the audio output device 128.

In an embodiment, a device 150 is operable to receive and process theaudio 140 or the signal input 144 and to determine one or more types ofMUP waveforms occurring alone or occurring in combination with other MUPwaveforms in the signal input 144 and/or audio 140. The device 150includes a processing module 52, EMG processing application 154, display156 and audio interface 158 and device memory 160. In an embodiment, thedevice 150 is a user device, such as a laptop, smartphone, smart tablet,smart watch, etc. In another embodiment, the device 150 or one or moreparts of the device 150, such as EMG processing application 154, isincorporated into the EMG system 110, such as part of the control module124. The device includes a display 156 that may be a touch screen toselect and control the device 150 or the device 150 may also includeother user interfaces such as keyboards, mouse, touchpads, etc.

In an embodiment, the device 150 detects the audio 140. For example, thedevice 150 includes an audio interface 158 such as a microphone that isoperable to detect the audio 140 from the audio output device 128 andgenerate a digital signal for analysis. For example, the audio interface158 may also include a DSP module 132 and analog processing module 134that processes the detected audio 140 and generates a digital signal. Inanother embodiment, the device 150 is operably coupled either wirelesslyor wired to the control module 124 or audio output device 128 to receivea digital or analog signal input 144 either wirelessly or via a wiredinterface from the EMG system 110.

The device 150 is operable to determine a type of waveform from theaudio 140 and/or the signal input 144. Different types of waveforms havedistinct sound patterns. For example, the device 150 is operable todetermine that a waveform is one type of a plurality of types ofwaveforms from its sound or wave pattern. In an embodiment, the device150 is also operable to quantify a number of sources of the waveforms inthe audio output 140 and/or the signal input 144, e.g. potentials thatrepresent the contraction of individual muscle fibers or a number ofmotor unit action potential (MUP) waveforms. The device 150 is thenoperable to record and display the results on display 156. The resultsare stored within the device memory 160 of the device 150. For example,the results on the display 156 may include a table such as Table 1above.

The EMG processing application 154 running on the processing module 152of the device 150 includes a sound or audio pattern recognitionapplication 162. The EMG processing application 154 is operable toprocess and correlate the input/sound pattern of the audio 140 with aparticular type of waveform. For example, the input/sound pattern of theaudio 140 is compared with a plurality of stored reference waveformpatterns. Correlation or other calculations are performed to determinethe stored reference pattern that is most similar or has leastdifferences with the input/sound pattern of the audio 140. The name ofthe type of the waveform is then output and displayed on the display 156and may be stored within the device memory 150.

FIG. 5 illustrates a graphical user interface (GUI) 220 displayed on thedisplay 156 of the device 150. The GUI 220 is only exemplary of thevarious options and information that may be displayed. The GUI 220 maybe separated into a number of different windows or menus or includeadditional or alternative windows or menus. In an embodiment, the GUI220 includes an option to select a muscle being tested by the EMG system110. The GUI 220 displays a plurality of group of muscles 200 for apatient from a drop down menu or window. The GUI 220 then displays aplurality of muscles 202 for the selected group of muscles. One of theplurality of muscles 202 is then selected

During EMG testing of the muscle, the device 150 receives the audio 140using a microphone placed an audible distance from the audio outputdevice 128, such as a speaker, of the EMG system 110. Alternatively, orin addition to the audio 140, the device 150 may receive an analog ordigital signal input 144 from the EMG system 110. A user of the device150 selects a group of muscles 200 and a specific muscle 202 from GUI220. The examiner may then start recording the audio 140 or the signalinput 144 generated in response to the sensing device 116 from theselected muscle 202. When audio 140 is generated during the EMG testing,EMG processing application 154 processes the audio 140. The GUI 220 maydisplay a sampling result 206, e.g. if sufficient data is collected forthe selected muscle, the screen tab may turn green. The device 150 maybe configured to not allow an examiner to select a second muscle fortesting unless adequate motor unit sampling has been completed for thefirst muscle and/or sufficient number of needle passes has beendetected, e.g. as indicated by a screen/tab turning red.

When sufficient data is received, the EMG processing application 154determines one or more types of waveforms and/or number of detectedwaveforms and displays the results 208 in a window or tab on the devicedisplay 156. The results may also be recorded in the device memory 136automatically or by selecting a record results 210 option. This processmay be repeated for a plurality of muscles in one group of muscles 200and/or for a plurality of muscles 202 in different groups of muscles200.

When EMG testing is complete, a list of muscles 202 shows the samplingresult 206 for an examined muscle as either green, meaning adequatesampling, or as red, meaning inadequate sampling. Adequate sampling mayalso be signaled by a specific signal (sound). Selecting a completedmuscle 202 displays the electrical activity recording and thus allowsfor additional review. Alternatively, a list of time based events forthe electrical activity or only the sound recording can be selected andreviewed separately. In another embodiment, the recording may becontinuous (in default settings without the need to select individualmuscles). The recording can be displayed continuously with recognizedevents synchronized with the sound recording. Alternatively, betweeneach muscle examined, there is a pause needle is removed from one muscleand before it is inserted into another muscle during the EMG procedure).The pause (certain length of time) will trigger the summation process ofevents for a given muscle. A list of time based events or only the soundrecording can be reviewed separately. In either case, the entirerecording can be scrolled back and forth. At the end of the EMG testing,the entire file can be saved by the device 150. The data can be savedand exported to the appropriate report generator program.

FIG. 6A illustrates a logical flow diagram of an embodiment of a method300 for analyzing EMG testing results from the audio 140. The method 300begins when the device 150 detects audio 140 using a microphone orsimilar device. The device 150 records the audio 140 and processes theaudio 140 from the EMG system 110 in step 306. The device 150 forexample converts the audio 140 into a digital signal for processing.

In step 308, the EMG processing application 154 operating withprocessing module 152 of device 150 processes the digital signal todetermine one or more types of waveforms from a plurality of types ofwaveforms in the audio 140. For example, using pattern recognitiontechniques, the device 150 determines that the digital signal includesan event, such as a type of waveform named “fibrillation potential”. Instep 310, device 150 then displays the result, e.g. “Fibrillationpotential” on the display 156. The time of occurrence of the event andthe number of occurrences can be determined and displayed as well.

For example, the EMG processing application 154 operating withprocessing module 152 of device 150 determines that the audio 140includes a positive sharp wave sound pattern and determines that thetype of waveform is named “positive sharp wave” and displays this or anabbreviation “PSW” on the display 156. A list of a plurality of type ofevents or waveforms that may be detected in the audio signal 140includes, inter alia, Long duration MUP, Short duration MUP, Polyphasicunit, short duration, Polyphasic units long duration, Normal insertion,Increased insertion, Cramp discharge, End-plate noise, End-plate spike,End-plate spike and noise, Fasciculation, Fibrillations, Positive wave,CRD (Complex repetitive discharges), Myotonic discharges, Myokymicdischarges, Neuromyotonic charges, and theirs subsets, but not limitedto.

In addition, the EMG processing application 154 operating withprocessing module 152 of device 150 is operable to quantify the numberof sources of waveforms or events detected in the audio 140. The resultsmay be used to populate one or more tables, such as Table 1 above, withwaveform data for display and storage. Furthermore, the device 150 mayexport the results to an appropriate report generator program. Therecordings of the audio 140 and the digital signal may be stored alongwith the results in step 312.

FIG. 6B illustrates a logical flow diagram of an embodiment of a method350 for analyzing EMG testing results from an input signal 144. Themethod 350 begins when the device 150 receives the input signal 144either wirelessly or via a wired connection from the EMG system 110. Thedevice 150 stores and processes the input signal 144 from the EMG system110 in step 352. In step 354, the EMG processing application 154operating with processing module 152 of device 150 processes the inputsignal 144 to determine one or more types of waveforms from a pluralityof types of waveforms. For example, using pattern recognitiontechniques, the device 150 determines that the input signal 144 includesan event, such as a type of waveform named “fibrillation potential”. Instep 356, device 150 then displays the result, e.g. “Fibrillationpotential” on the display 156. The time of occurrence of the event andthe number of occurrences can be determined and displayed as well. Inaddition, the EMG processing application 154 operating with processingmodule 152 of device 150 is operable to quantify the number of sourcesof waveforms or events detected in the input signal 144. The results maybe used to populate one or more tables, such as Table 1 above, withwaveform data for display and storage. Furthermore, the device 150 mayexport the results to an appropriate report generator program. The inputsignal 144 may be stored along with the results in step 358.

FIG. 7A illustrates a logical flow diagram of another embodiment of amethod 400 for analyzing EMG testing results from audio. The method 400includes detecting the audio 140 using a microphone or other sounddetection device and recording the audio 140. The audio 140 is processedin step 402 to filter the desired electrical activity input events(e.g., the desired EMG sound pattern events) from non-desired events,such as speech audio input or noise. In an embodiment, in step 404, thefiltered audio is decomposed into one or more source MUAPTs. Forexample, the filtered audio may include a plurality of individual motorunit action potential trains (MUAPTs). These individual MUAPTs areidentified and may be displayed. For each of the MUP waveforms in anMUAPT, the device 150 detects a sound pattern in step 406.

A waveform database is accessed that stores reference sound patterns andnames of associated types of waveforms in step 408. A detected soundpattern in the recorded audio is correlated with the reference soundpatterns until a match is determined in step 410. The associated type ofwaveform is thus determined based on the matching reference soundpattern in step 412. The result is displayed in step 414 and recorded instep 416 along with the audio input.

FIG. 7B illustrates a logical flow diagram of another embodiment of amethod 450 for analyzing EMG testing results from an input signal 144.The method 400 includes receiving the input signal 140 wirelessly or viaa wired interface and storing the input signal 144. The input signal 144is processed in step 452 to filter the desired electrical activity inputevents (e.g., the desired EMG pattern events) from non-desired events,e.g., noise. In an embodiment, in step 454, the filtered signal isdecomposed into one or more source MUAPTs. For example, the filteredsignal may include a plurality of individual motor unit action potentialtrains (MUAPTs). These individual MUAPTs are identified and may bedisplayed. For each of the MUP waveforms in an MUAPT, the device 150detects an input signal pattern in step 456.

A waveform database is accessed that stores reference wave patterns andnames of associated types of waveforms in step 458. A detected wavepattern in the filtered signal is correlated with the reference wavepatterns until a match is determined in step 460. The associated type ofwaveform is thus determined based on the matching reference wave patternin step 462. The result is displayed in step 464 and recorded in step466.

FIG. 8 illustrates a schematic block diagram of an embodiment of awaveform database 500. The waveform database 500 is stored, for example,in device memory 160 or other memory accessible by the EMG processingapplication 154 or processing module 152 of device 150. The waveformdatabase 500 includes a plurality of waveform types 502 and reference(Ref) sound (e.g., wave) patterns 504. Since a waveform type 502 mayhave slight variations, one or more reference sound patterns 504 may beassociated with a waveform type 502. Various characteristics (Char) 506may be stored and associated with a reference sound pattern 504. Forexample, a characteristic 506 may include a typical duration, peakvoltage, number of peaks, repetition rate, etc. for the reference soundpattern. The detected sound pattern for a waveform is correlated withone or more reference sound patterns in the waveform database 500 untila match is determined. The type of waveform is thus determined based onthe matching reference sound patterns from the waveform database 500.

FIG. 9 illustrates a schematic block diagram of an embodiment of apatient database 600. The patient database 600 includes EMG testingresults for a plurality of patients. For a particular patient, thepatient database 600 includes a list of tested muscle groups 602 and oneor more tested muscles 604 in each tested muscle group 602. For a testedmuscle, the type of condition 608 of the EMG testing is stored, such asspontaneous activity, volitional activity and recruitment. For each typeof condition, the one or more detected waveform types 616 are stored aswell as characteristic data 612, such as MUP amplitude and duration andother characteristics as shown in Table 1. The audio input 614 is alsostored so that it may be retrieved in whole or in part, e.g. audio inputby event 614 or audio input by time 618.

For example, the EMG processing application 154 provides a graphicaluser interface to retrieve the audio 140 and/or list events with thetime of occurrence from EMG testing of a patient. Time based events mayalso be replayed, such as recorded sound and waveform types. Forexample, the sound and the waveform of a fibrillation potential duringtesting of a muscle may be retrieved. The time of occurrence of theevent is stored and may be retrieved during the playback review. Thenumber of occurrences can be determined and stored as one of thecharacteristics 612. In another embodiment, a duration of the audiooutput 140, such as between a time 1 and a time 2 may be retrieved ofthe EMG testing. As such, recording can be displayed continuously withrecognized time based events synchronized with the sound recording instep 217. Alternatively, a list of time based events or only the soundrecording can be reviewed separately. In another embodiment therecording can be continuous (in default settings without the need toselect individual muscles) again, recording can be displayedcontinuously with recognized events synchronized with the waveformand/or sound recording. Alternatively, a list of time based events oronly the sound recording or only the waveform recording can be reviewedseparately. In either case, the entire recording of the audio 140 may bescrolled back and forth. At the end of the exam, the entire file can besaved within the device memory 160 or memory 136.

As may be used herein, the terms “substantially” and “approximately”provides an industry-accepted tolerance for its corresponding termand/or relativity between items. Such an industry-accepted toleranceranges from less than one percent to fifty percent and corresponds to,but is not limited to, component values, integrated circuit processvariations, temperature variations, rise and fall times, and/or thermalnoise. Such relativity between items ranges from a difference of a fewpercent to magnitude differences. As may also be used herein, theterm(s) “operably coupled to”, “coupled to”, and/or “coupling” includesdirect coupling between items and/or indirect coupling between items viaan intervening item (e.g., an item includes, but is not limited to, acomponent, an element, a circuit, and/or a module). As may further beused herein, inferred coupling (i.e., where one element is coupled toanother element by inference) includes direct and indirect couplingbetween two items in the same manner as “coupled to”. As may evenfurther be used herein, the term “operable to” or “operably coupled to”indicates that an item includes one or more of functions, components,power connections, input(s), output(s), etc., to perform, whenactivated, one or more its corresponding functions and may furtherinclude direct or inferred coupling to one or more other items. As maystill further be used herein, the term “associated with”, includesdirect and/or indirect association or origination or coupling ofseparate items and/or one item being embedded within another item.

The term “module” is used in the description of the various embodimentsof the disclosure. A “module” indicates a device that includes one ormore hardware components, such as a single processing device or aplurality of processing devices. A module may include a memory andsoftware stored on the memory for performing one or more functions asmay be described herein. Note that, the hardware components of a modulemay operate independently and/or in conjunction with software and/orfirmware. As used herein, a module may contain one or more sub-modules,each of which may be one or more modules. As may also be used herein, amodule may include one or more additional components.

The description and figures includes functional building blocks. Theboundaries and sequence of these functional building blocks may havebeen arbitrarily defined herein for convenience of description.Alternate boundaries and sequences can be defined so long as thespecified functions and relationships are appropriately performed. Anysuch alternate boundaries or sequences are thus within the scope andspirit of the claims. Similarly, flow diagram blocks may also have beenarbitrarily defined herein to illustrate certain significantfunctionality. To the extent used, the flow diagram block boundaries andsequence could have been defined otherwise and still perform the certainsignificant functionality. Such alternate definitions of both functionalbuilding blocks and flow diagram blocks and sequences are thus withinthe scope and spirit of the claims. One of average skill in the art willalso recognize that the functional building blocks, and otherillustrative blocks, modules and components herein, can be implementedas illustrated or by discrete components, application specificintegrated circuits, processors executing appropriate software and thelike or any combination thereof.

The disclosure may have also been described, at least in part, in termsof one or more embodiments. An embodiment of the disclosure is usedherein to illustrate the disclosure, an aspect thereof, a featurethereof, a concept thereof, and/or an example thereof. A physicalembodiment of an apparatus, an article of manufacture, a machine, and/orof a process that embodies the disclosure may include one or more of theaspects, features, concepts, examples, etc. described with reference toone or more of the embodiments discussed herein. Further, from figure tofigure, the embodiments may incorporate the same or similarly namedfunctions, steps, modules, etc. that may use the same or differentreference numbers and, as such, the functions, steps, modules, etc. maybe the same or similar functions, steps, modules, etc. or differentones.

While particular combinations of various functions and features of thedisclosure have been expressly described herein, other combinations ofthese features and functions are likewise possible. The disclosure isnot limited by the particular examples disclosed herein and expresslyincorporates these other combinations.

The invention claimed is:
 1. A device, comprising: a display; a memory;an interface configured to receive an output signal of a needleelectromyography (EMG) device, wherein a needle electrode is insertedinto at least one muscle and records electrical activity of at least onemuscle fiber in the at least one muscle and wherein the output signalrepresents one or more waveforms of the electrical activity of the atleast one muscle fiber in the at least one muscle; at least oneprocessing device; and an EMG processing application stored in thememory and operable with the processing device to: process the outputsignal; compare the processed output signal to a plurality of outputpatterns; detect at least one pattern of the plurality of outputpatterns using the processed output signal; access a waveform databasethat includes the plurality of output patterns and associated waveformtypes of electrical activity of muscle fibers, wherein the associatedwaveform types of the electrical activity of the muscle fibers includeone or more of: insertional activity waveform, spontaneous activitywaveform, volitional activity waveform or recruitment waveform; identifyat least one type of waveform of the plurality of types of waveformsassociated with the detected at least one pattern; and display theidentified at least one type of waveform on the display.
 2. The deviceof claim 1, wherein the at least one processing device is furtheroperable to: diagnose at least one condition based on the identified atleast one type of waveform.
 3. The device of claim 1, wherein the memoryincludes the waveform database storing the plurality of output patternsand the associated waveform types of electrical activity of musclefibers, wherein the associated waveform types of electrical activity ofmuscle fibers include one or more of: Normal insertion, Increasedinsertion, Fasciculations, Fibrillations, or Positive waves.
 4. Thedevice of claim 3, wherein the processing device is operable to processthe output signal by: detecting the at least one pattern of theplurality of output patterns in the output signal; accessing thewaveform database; and correlating the at least one pattern with atleast one of the plurality of associated waveform types of electricalactivity of muscle fibers stored in the waveform database.
 5. The deviceof claim 1, wherein the processing device is further operable to:quantify a number of motor units generating the output signal; anddetermine a count of repetitions for one or more of the motor unitsduring a portion of the output signal.
 6. The device of claim 3, whereinthe memory further includes a patient database for storing the outputsignal and the identified at least one type of waveform.
 7. A method,comprising: receiving an output signal of a needle EMG device, whereinthe output signal represents electrical activity of at least one musclefiber; processing the output signal; identifying a first waveform typein the output signal of the electrical activity of the at least onemuscle fiber; identifying a second waveform type in the output signal ofthe electrical activity of the at least one muscle fiber; and displayinga first name of the first waveform type and a second name of the secondwaveform type and a number of each of the first waveform types and thesecond waveform types on a display, wherein the first waveform type andthe second waveform type of the electrical activity of the at least onemuscle fiber includes two or more of: insertional waveform, spontaneousactivity waveform, volitional activity waveform or recruitment waveform.8. The method of claim 7, further comprising: diagnosing at least onecondition based on at least one of the first waveform type or the secondwaveform type.
 9. The method of claim 8, further comprising: storing aplurality of reference output patterns and associated waveform types ina waveform database.
 10. The method of claim 9, wherein identifying thefirst waveform type in the output signal of the electrical activity ofthe at least one muscle fiber comprises: detecting an output pattern inthe output signal of the needle EMG device; accessing the waveformdatabase; correlating the detected output pattern in the output signalwith one of the plurality of reference output patterns stored in thewaveform database; and identifying the associated waveform type in thewaveform database with the correlated reference output pattern.
 11. Themethod of claim 10, further comprising: quantifying a number of motorunits generating the output signal; and determining a count ofrepetitions for one or more of the motor units during a portion of theneedle EMG output.
 12. The method of claim 11, further comprising:storing a patient database, wherein the patient database includes theoutput signal of the needle EMG and a name of the first waveform typeand a name of the second waveform type and a number of each of the firstwaveform type and the second waveform type.